Calwood Nutritionals, LLC.

CLOSEOUT LETTER Calwood Nutritionals, LLC. MARCS-CMS 482185 — July 30, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Food & Beverages Recipient: Recipient Name Gary J. Calton Recipient Title Managing Member Calwood Nutritionals, LLC. 1228 Hay Meadow Ln. Sykesville , MD 21784-5438 United States Issuing Office: Center for Food Safety and Applied Nutrition 6000 Metro Drive Suite 101 Baltimore , MD 21215 United States 410- 779-5455 Dear Mr. Calton, On December 12, 2018, The Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#482185), dated February 2, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Rochelle B. Young, RPh, MSA Human and Animal Food Division 2 East Compliance Officer Content current as of: 08/01/2019 Regulated Product(s) Food & Beverages